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    Desing Quality Engineer - Tijuana, México - Corza Medical Tijuana

    Corza Medical Tijuana
    Corza Medical Tijuana Tijuana, México

    hace 2 semanas

    Default job background
    Descripción
    y detalle de las actividades

    • Guide the quality assurance efforts in the design and development of technical transfers
    • Appropriately document experiment plans and results, including protocol writing and reports
    • Lead the investigation, resolution and prevention of product and process nonconformance's (e.g. CAPAs/HHEs)
    • Participate in or lead teams in supporting quality disciplines, decisions, and practices
    • Support design reviews and transfers, providing inputs on quality requirements, ensuring gap analysis and supporting risk mitigation strategies
    • Provide guidance and support to other engineers to ensure quality integrity
    • Support the development, implement various product, and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
    • Work with design engineering in the completion of product verification and validation
    • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
    • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
    • Design and conduct experiments for process optimization and/or improvement.
    Experiencia y requisitos

    • Bachelor's degree in Engineering or equivalent education and experience
    • 3+ years of experience working in a Design Quality Engineering role within a medical device industry
    • Strong knowledge of quality management systems
    • Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities)
    • Strong Knowledge of statistical analysis tools and their use in product design and manufacturing.
    • Six Sigma training is a must.
    • Experience in creating design control documentation during the whole lifecycle of the development process
    • Experience with previous transfer of products from design to volume manufacturing
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Strong project management and leadership skills, including the demonstrated ability to lead project teams and resolve quality-related issues in a timely and effective manner
    • Advanced computer skills, including statistical/data analysis and report writing skills
    • Experience implementing various product and process improvement methodologies
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
    • Fluent in Spanish and English required
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